an open-label study to evaluate the efficacy of re-treatment for patients with a history of etanercept use

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.


Eligibility criteria:
inclusion criteria: * subjects with psoriasis who have previously been treated with etanercept for a minimum of 6 months and discontinued treatment due to loss of efficacy. every attempt will be made to obtain loss of efficacy history from the subject's medical chart;when etanercept was commenced and terminated and description of patient's psoriasis on termination and details of new treatment commenced. subjects must have failed their latest psoriasis treatment after a period of three months. this will be measured as a pga of ≥ 3. * there is no specific requirement as to when prior treatment with etanercept occurred and no requirement as to what type of treatment(s) used between initial and subsequent treatments. * are ≥ 18 years of age * pga ≥ 3 * bsa minimum of 5% tuberculosis inclusion criteria * have no history of latent or active tb prior to screening. * have no signs or symptoms suggestive of active tb upon medical history and/or physical examination. * have had no recent close contact with a person with active tb. * within 1 month prior to the first administration of study have a negative tuberculin skin test. * the ability to give written informed consent and comply with study procedures. exclusion criteria: * current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit. * known hypersensitivity to enbrel® (etanercept) or any of its components or known to have antibodies to etanercept. * latex sensitivity \[nb: only applicable if they are using prefilled syringe or prefilled sureclick™ autoinjector presentations\] * prior or concurrent use of cyclophosphamide therapy * concurrent sulfasalazine therapy. * a positive hbv test or known history of any other immuno-suppressing disease. * any mycobacterial disease or high risk factors for tuberculosis (tb), such as family member with tb, positive purified protein derivative (ppd) or taking anti-tuberculosis medication. * active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits. * history of listeriosis, histoplasmosis, chronic or active hepatitis b infection and hepatitis c, human immunodeficiency virus (hiv) infection, immunodeficiency syndrome, chronic recurring infections or active tb, or other opportunistic infections * if etanercept was previously discontinued due to a serious adverse event * severe comorbidities (diabetes mellitus requiring insulin; chf of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic bp \ 160 or diastolic bp \> 100 mm hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years \[other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer\]) * systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder. * use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine. * any condition or circumstances judged by the patient's physician \[or the investigator or medically qualified study staff\] to render this clinical trial detrimental or otherwise unsuitable for the patient's participation. * female subjects who are pregnant, nursing or planning pregnancy (both men and women) and not using acceptable methods of birth control during the trial (hormonal, barriers, abstinence). * women who are breast feeding history of non-compliance with other therapies. * history of alcohol abuse within the last 12 months * concurrent use of anakinra * subjects who cannot discontinue any of the drugs below for 2 weeks prior to the baseline visit or during the study; a two week wash out period is appropriate as it would be unethical to expect subjects whose disease if flaring to remain untreated for a longer period of time. the first dose of etanercept will be administered two weeks after the last biologic dose. * immunosuppressants, antimalarials, or sulfasalazine. * other ani-tnfs * cyclosporine * efalizumab * azathioprine * hydroxyurea * live vaccines * tacrolimus * oral retinoids (isotretinoin,acitretin,bexarotene) * ultra violet light therapies